Tubersol® (Tuberculin Purified Protein Derivative, Mantoux), 5 TU / 0.1 mL, Various Sizes

Tubersol® (Tuberculin Purified Protein Derivative, Mantoux), 5 TU / 0.1 mL, Various Sizes

Single Vial (EA/1)

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SKU: PAR 42023010401-1

Product Specifications

Specification 1 mL Vial Option (10 Tests) 5 mL Vial Option (50 Tests)
Manufacturer / Brand Sanofi Pasteur Limited / TUBERSOL® Sanofi Pasteur Limited / TUBERSOL®
Manufacturer SKU / Item # 49281075221 49281075222
NDC Number 49281-752-21 49281-752-22
Active Ingredient Tuberculin Purified Protein Derivative (PPD) Tuberculin Purified Protein Derivative (PPD)
Strength / Dosage 5 Tuberculin Units (TU) per 0.1 mL dose 5 Tuberculin Units (TU) per 0.1 mL dose
Total Content per Vial 1 mL (Up to 10 tests) 5 mL (Up to 50 tests)
Container Type Glass Multiple-Dose Vial (MDV) Glass Multiple-Dose Vial (MDV)
Administration Route Intradermal (ID) (Mantoux Technique) Intradermal (ID) (Mantoux Technique)
Formulation Phenol-Preserved (0.35%) / Polysorbate 80 Phenol-Preserved (0.35%) / Polysorbate 80
Storage Temperature 2°C to 8°C (36°F to 46°F) (Refrigerate) 2°C to 8°C (36°F to 46°F) (Refrigerate)
Packaging Configuration 1 Vial per Box 1 Vial per Box
Regulatory Category Prescription-Only (Rx) / BLA103913 Prescription-Only (Rx) / BLA103913

Key Features & Clinical Applications

  • Standardized Mantoux Skin Testing: Indicated as a diagnostic aid to detect latent or active infection with Mycobacterium tuberculosis in adults and pediatric populations.

  • Master-Batch Consistency: Formulated from a single master batch of tuberculin (PPD-S equivalent) to ensure standardized reactivity and eliminate batch-to-batch variation in induration reading.

  • Polysorbate 80 Stabilized: Contains Tween-80 (Polysorbate 80) as a stabilizing agent to prevent adsorption of the protein derivative to glass vial surfaces and syringe walls.

  • Flexible Clinic Packaging: Available in compact 1 mL (10-test) vials for low-volume clinics or high-capacity 5 mL (50-test) vials for high-volume occupational health screening, employee health departments, and public health facilities.

⚠️ Administration Requirement: Administer strictly via intradermal injection (Mantoux method) using a tuberculin syringe and 26- or 27-gauge needle. Do not administer subcutaneously or intravenously. Subcutaneous injection results in a false-negative or uninterpretable reading.

⚠️ Reading Window: The test must be read by a trained healthcare professional 48 to 72 hours post-administration by measuring the transverse diameter of induration (palpable swelling) in millimeters, not erythema.

⚠️ Contraindications: Contraindicated in patients with known hypersensitivity to tuberculin PPD, prior severe local reaction (e.g., necrosis, blistering, ulceration) to a tuberculin skin test, or documented active tuberculosis infection.

Unit of Measure

Vial (EA/1)

Size (mL)

1 mL Vial (10 Tests), 5 mL Vial (50 Tests)

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