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Pharmaxis Previews New Bronchial Challenge Test at the Annual Meeting of the American College of Allergy, Asthma and Immunology
Date:11/10/2010

Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention, the World Anti-Doping Agency and the Australian Asthma Management Handbook.

ARIDOL is the only dry powder bronchial challenge test approved for use in the U.S.

Indication

Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.  

ARIDOL is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Important Safety Information

WARNING: RISK OF SEVERE BRONCHOSPASM

Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm.  Bronchial challenge testing with ARIDOL is for diagnostic purposes only.  Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area.  If severe bronchospasm occurs it should be treated immediately by administration of a short acting inhaled beta-agonist. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV1 <1-1.5 liters or <70% of the predicted values).

ARIDOL is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules.  The product is also c
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SOURCE Pharmaxis
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5. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
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