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PPD-T
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- Stock: Zabrana online prodaje
- Brand: TORLAK
- Model: BR-1671654156
PPD-T® tuberculin is a solution of purified protein derivative of tuberculin, obtained from the culture filtrate of Mycobacterium tuberculosis. It belongs to the diagnostic agents and is given intradermally as the Mantoux (tuberculin skin) test.
In people previously sensitised by mycobacteria, tuberculin injected into the skin causes a delayed T-cell-mediated hypersensitivity reaction, which is measured after 48 to 72 hours. It is manufactured by the Institute of Virology, Vaccines and Sera Torlak, Belgrade.
Important warning
- Supply status: for use in a healthcare facility.
- For intradermal use only – it must not be given intravenously, intramuscularly or subcutaneously.
- It must not be used in case of allergy to its ingredients or after a previous severe skin reaction to tuberculin.
- The result may be falsely negative in immunosuppression, severe infections and after live vaccines.
What PPD-T tuberculin is used for and how the test is performed
Key facts about the medicine
| Name of the medicine | PPD-T® tuberculin, solution for injection |
|---|---|
| Active substance | purified protein derivative of tuberculin for human use |
| Strength | 3 IU in 0.1 mL (one dose) |
| Pharmaceutical form | solution for injection, intradermal |
| Group | diagnostic agents |
| Pack | 10 glass vials of 2.5 mL |
| Marketing authorisation holder and manufacturer | Institute of Virology, Vaccines and Sera Torlak, Serbia |
| Supply status | use in a healthcare facility |
Indications
- diagnostic antigen to determine tuberculin hypersensitivity in people not vaccinated with BCG, when the need for vaccination is being considered;
- aid in diagnosing Mycobacterium tuberculosis infection in adults with suspected infection (including HIV-positive patients) and in children at high risk of the disease.
Dosage and method of administration
One dose is 0.1 mL. A healthcare professional injects it intradermally into the front of the left forearm, at the junction of the upper and middle third, along the long axis, using a single-use tuberculin syringe and needle. The injection is given without delay because tuberculin can adsorb to the syringe surface.
The result is read 48 to 72 hours after the injection by measuring the induration (hardening) across the long axis of the forearm. A higher dose reduces the specificity of the test and increases the risk of side effects.
Contraindications – when the test must not be used
- allergy to the active substance or excipients (including chinosol and polysorbate 80);
- a previous severe skin reaction to this product.
Precautions and possible false-negative results
In active tuberculosis the test is used with caution, as the local reaction may be stronger; in severe forms (e.g. miliary tuberculosis) reactivity may be suppressed. Tuberculin reactivity may be reduced in:
- severe bacterial and viral infections (HIV, infectious mononucleosis, measles, chickenpox, influenza);
- malignant diseases, especially lymphoma, and UV therapy;
- sarcoidosis and chronic kidney failure;
- dehydration and malnutrition;
- immunosuppression due to disease, surgery or medicines (e.g. 15 mg or more of prednisone daily for at least one month);
- recent vaccination with live viral vaccines (OPV, MMR, varicella, yellow fever).
According to the leaflet, the World Health Organization no longer recommends skin tests for repeat tuberculosis vaccination; under the national programme, BCG vaccination is given to newborns.
Interactions with other medicines and vaccines
After a live viral vaccine the test should be postponed for 4–6 weeks or performed on the same day as the vaccination, with reading at 48–72 hours. Tuberculin must not be mixed with other medicines, sera or vaccines in the same syringe. Tell your doctor about all medicines you take.
Pregnancy and breast-feeding
No teratogenic effects of the tuberculin skin test have been reported in pregnant women. Because active maternal tuberculosis carries a high risk for the newborn, the doctor may, when needed, perform the test in the second or third trimester after weighing benefits and risks.
Driving and using machines
No data are available.
Possible side effects
Common: pain, irritation or discomfort at the injection site immediately after administration; headache, nausea, dizziness, malaise, raised temperature.
Uncommon: enlarged regional lymph nodes; anaphylaxis (severe allergic reaction).
Rare: granuloma, blisters, ulceration or skin necrosis at the injection site in marked hypersensitivity. Very rare: inflammation of the lymphatic vessels.
Medical treatment for a possible anaphylactic reaction must always be available after the test.
When to seek medical help immediately
- difficulty breathing, swelling of the face or throat, dizziness or feeling faint after the injection;
- blisters, an ulcer or darkening of the skin at the test site;
- a red streak from the injection site towards the armpit, or painful swollen lymph nodes;
- a high temperature after the test.
Pharmacist's advice
Be sure to return for the reading within the scheduled 48 to 72 hours after the injection. The result is read by a healthcare professional, who measures the induration (hardening) of the skin across the long axis of the forearm.
Before the test, tell the healthcare professional if you have recently received a live vaccine (MMR, chickenpox, yellow fever), take corticosteroids or other medicines that weaken immunity, or have recently had a severe viral infection – these can give a false-negative result.
Availability and price
PPD-T tuberculin is used only in healthcare facilities and is not dispensed to patients. This page is for information only and is not an offer to sell the medicine online.
For a tuberculin test, contact your family doctor or the competent healthcare facility.
Composition, pack and manufacturer
- Active substance: purified protein derivative of tuberculin for human use, 3 IU in 0.1 mL.
- Excipients: chinosol; polysorbate 80; disodium phosphate dihydrate; potassium dihydrogen phosphate; sodium chloride; water for injections.
- Appearance: colourless to slightly yellow solution, odourless or with a slightly characteristic odour.
- Pack: 10 colourless glass vials (10 × 2.5 mL).
- Marketing authorisation holder and manufacturer: Institute of Virology, Vaccines and Sera Torlak, Belgrade. A conditional 12-month authorisation has been issued for this medicine.
Storage
- Keep out of the sight and reach of children.
- Store in the original package in a refrigerator at 2–8 °C. Do not freeze.
- After first opening, the vial should be used within 8 hours, stored at 2–8 °C.
- Do not use after the expiry date.
Frequently asked questions
When is the Mantoux test read?
The result is read 48 to 72 hours after the intradermal injection by measuring the induration across the long axis of the forearm.
What can cause a false-negative tuberculin test?
According to the leaflet: immunosuppression (including corticosteroids), severe bacterial and viral infections, lymphoma, sarcoidosis, chronic kidney failure, malnutrition and a recent live viral vaccine.
Can the test be done after the MMR vaccine?
The test should be postponed for 4 to 6 weeks after a live vaccine or done on the same day as the vaccination.
Can a tuberculin test be done during pregnancy?
No teratogenic effects have been reported; when needed, the doctor performs it in the second or third trimester after weighing benefits and risks.
Sources
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For all orders received up to 12h from Monday to Friday, the approximate delivery time is 2-4 business days for the whole territory of the Republic of Serbia. In case the order is placed on weekends (Saturdays and Sundays), the delivery is done as well as for the orders received on Monday - so next business day.
Deliveries are not made on Saturdays and Sundays.
Additional information
The items will be packed so that they cannot be damaged by normal handling of the goods in transit. When picking up the product, the buyer is obliged to check for any damage and immediately advertise it to the courier who delivered the goods, or refuse to take over the shipment, which shows the external damage. Any subsequent product claims for shipping damage will not be considered.
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The courier service delivers the goods to the address, ie. does not bring into the living space.
Delivery restrictions on goods
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Shipping cost
For the territory of the Republic of Serbia:
For goods ordered up to 5.000,00 RSD, delivery charge is 350.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
- Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
- Zone II (Other European countries) - 1,790.00 RSD
- Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD
Delivery time is 15 days or more (depending on the country of delivery)
For export of goods abroad through DHL service, the shipping price is 2,700.00 RSD. Delivery time is 1-5 business days (depending on the country of delivery)
Shipping cost is with tax. The price includes the delivery of the parcel to the buyer's address with the associated tax and customs at the seller's expense. A possible additional cost may be a customs charge against the buyer, depending on the country to which the package is being shipped.
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