Finished product reference
Tuberculin Ppd
Injection, Solution · Intradermal · 3 mL
- List code
- 52684
- Pharmacologic class
- Diagnostic agent (tuberculin purified protein derivative)
What it is and how it works
Tuberculin PPD is a purified protein fraction obtained from cultures of Mycobacterium tuberculosis. Injected intradermally, it elicits a delayed-type (type IV) hypersensitivity reaction with induration at the site in individuals previously sensitised by mycobacterial infection or BCG vaccination.
Indications
Mantoux tuberculin skin test to aid diagnosis of latent or active tuberculosis infection, contact tracing and screening before BCG vaccination or immunosuppressive therapy.
Dosage and administration (summary)
0.1 mL (containing the standard number of tuberculin units for the product) by intradermal injection on the forearm; induration is read after 48–72 hours and interpreted according to national guidelines.
Contraindications
Previous severe reaction to tuberculin (vesiculation, ulceration or necrosis); generalised skin disease at the test site.
Warnings and precautions
Must be injected intradermally, not subcutaneously. False-negative results may occur in immunosuppression, HIV infection, malnutrition, severe or recent tuberculosis, recent viral infections and within about 4 weeks of live viral vaccines (e.g. MMR); false positives may follow BCG or non-tuberculous mycobacterial exposure. Anaphylaxis is very rare; resuscitation facilities should be available.
Pregnancy
May be used in pregnancy; the test is considered safe and valid.
Storage and supply
Store refrigerated at 2–8 °C, protected from light; do not freeze; use opened vials within the period stated by the manufacturer.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.