sanofi pasteur Section 1.3.1 Product Monograph 299 – TUBERSOL® PRODUCT MONOGRAPH TUBERSOL® Tuberculin Purified Protein Derivative (Mantoux) Solution for injection Diagnostic Antigen to aid in the detection of infection with Mycobacterium tuberculosis ATC Code: V04CF01 Manufactured by: Sanofi Pasteur Limited Toronto, Ontario, Canada Control # 157184 Date of Approval: 02 October 2012 Product Monograph Template – Schedule D Page 1 of 18 sanofi pasteur Section 1.3.1 Product Monograph 299 – TUBERSOL® Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ........................................................... 4 SUMMARY PRODUCT INFORMATION .................................................................................. 4 Route of Administration .................................................................................................................... 4 Dosage Form / Strength ..................................................................................................................... 4 Active Ingredients ............................................................................................................................. 4 Clinically relevant Non-medicinal Ingredients ................................................................................. 4 DESCRIPTION ............................................................................................................................... 4 INDICATIONS AND CLINICAL USE ........................................................................................ 4 CONTRAINDICATIONS ............................................................................................................... 5 WARNINGS AND PRECAUTIONS ............................................................................................. 5 General…. ......................................................................................................................................... 5 Limitations in Predictive Value ......................................................................................................... 6 False Positive Tests ........................................................................................................................... 6 False Negative Tests .......................................................................................................................... 6 Hypersensitivity ................................................................................................................................. 6 Special Populations ........................................................................................................................... 7 Pediatrics…. ...................................................................................................................................... 7 Pregnant Women ............................................................................................................................... 7 Nursing Mothers ................................................................................................................................ 7 ADVERSE REACTIONS ............................................................................................................... 7 Reporting of Adverse Events............................................................................................................. 8 DRUG INTERACTIONS ............................................................................................................... 8 Diagnostic Test – Vaccine Interactions ............................................................................................. 8 DOSAGE AND ADMINISTRATION ........................................................................................... 9 Method of Administration ................................................................................................................. 9 Interpretation of the Test ................................................................................................................... 9 The Booster Effect and Two-step Testing ....................................................................................... 10 OVERDOSAGE ............................................................................................................................. 11 Product Monograph Template – Schedule D Page 2 of 18 sanofi pasteur Section 1.3.1 Product Monograph 299 – TUBERSOL® ACTION AND CLINICAL PHARMACOLOGY ...................................................................... 11 Mechanism of Action ...................................................................................................................... 11 STORAGE AND STABILITY ..................................................................................................... 11 DOSAGE FORMS, PACKAGING AND COMPOSITION ...................................................... 11 PART II: SCIENTIFIC INFORMATION .................................................................................. 13 PHARMACEUTICAL INFORMATION ................................................................................... 13 Drug Substance ................................................................................................................................ 13 Product Characteristics .................................................................................................................... 13 Additional Relevant Information ..................................................................................................... 13 PART III: CONSUMER INFORMATION ................................................................................ 17 ABOUT THIS MEDICATION .................................................................................................... 17 WARNINGS AND PRECAUTIONS ........................................................................................... 17 INTERACTIONS WITH THIS MEDICATION ....................................................................... 18 PROPER USE OF THIS MEDICATION ................................................................................... 18 SIDE EFFECTS AND WHAT TO DO ABOUT THEM ........................................................... 18 REPORTING SUSPECTED SIDE EFFECTS ........................................................................... 18 TESTING INSTRUCTIONS ........................................................................................................ 18 HOW TO STORE IT .................................................................................................................... 18 MORE INFORMATION .............................................................................................................. 18 Product Monograph Template – Schedule D Page 3 of 18 sanofi pasteur Section 1.3.1 Product Monograph 299 – TUBERSOL® TUBERSOL® Tuberculin Purified Protein Derivative (Mantoux) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Intradermal Injection Dosage Form / Strength Solution Five (5) Tuberculin units (TU) per test dose of 0.1 mL. Active Ingredients Tuberculin Purified Protein Derivative of Mycobacterium tuberculosis Clinically relevant Non-medicinal Ingredients Excipients: Phenol, Polysorbate 80 For a complete listing see DOSAGE FORMS, PACKAGING AND COMPOSITION section. DESCRIPTION TUBERSOL® is a clear, colourless liquid. TUBERSOL® [Tuberculin Purified Protein derivative (Mantoux)] (1) for intradermal tuberculin testing is prepared from a large Master Batch Connaught Tuberculin (CT68) (2) and is a cell-free purified protein fraction obtained from a human strain of M. tuberculosis grown on a protein-free synthetic medium and inactivated. (2) The use of a standard preparation from a single batch (CT68) has been adopted in order to eliminate batch to batch variation by the same manufacturer. (2) INDICATIONS AND CLINICAL USE TUBERSOL® [Tuberculin Purified Protein Derivative (Mantoux)] is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. There are three general situations where risk of disease is increased: • Recent infection – most commonly contacts of a recently diagnosed patient with active contagious pulmonary TB, or immigrants within five years of their arrival in Canada from countries where TB is still common. (3) (4) Product Monograph Template – Schedule D Page 4 of 18 sanofi pasteur Section 1.3.1 Product Monograph 299 – TUBERSOL® • Increased risk of reactivation due to impaired immunity. This includes Human Immunodeficiency Virus (HIV) infection, diabetes, renal failure, corticosteroids or other immuno-suppressant medication and pulmonary silicosis. (4) (5) (6) • Radiographic evidence of old healed inactive TB but no prior treatment. (4) Previous BCG vaccination is not a contraindication to tuberculin testing. (4) TUBERSOL® may be used as an aid in the diagnosis of tuberculosis infection in persons with a history of BCG vaccination. The repeated testing of uninfected persons does not sensitize them to tuberculin. (7) CONTRAINDICATIONS TUBERSOL® should not be administered to: • persons with known hypersensitivity to TUBERSOL® or to any components of the formulation or container. (For a complete listing, see the DOSAGE FORMS, PACKAGING AND COMPOSITION section.), • persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock or ulcerations) to a previous tuberculin skin test, (4) • persons with documented active tuberculosis