Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
REMEDYREPACK INC.
ALBUTEROL SULFATE
ALBUTEROL 90 ug
PRESCRIPTION DRUG
New Drug Application
PROAIR HFA- ALBUTEROL SULFATE AEROSOL, METERED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROAIR HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROAIR HFA INHALATION AEROSOL PROAIR HFA (ALBUTEROL SULFATE) INHALATION AEROSOL INITIAL U.S. APPROVAL: 1981 INDICATIONS AND USAGE PROAIR HFA Inhalation Aerosol is a beta -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2) DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient. ( 2.1) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. ( 2.2) Priming information: Prime PROAIR HFA before using for the first time, or when the inhaler has not been used for more than 2 weeks. To prime PROAIR HFA, release 3 sprays into the air away from the face. Shake well before each spray. ( 2.3) Cleaning information: At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly. ( 2.3) PROAIR HFA inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first. ( 2.3) DOSAGE FORMS AND STRENGTHS Inhalation Aerosol: Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Supplied in 8.5-g canister containing 200 actuations. ( 3) CONTRAINDICATIONS Hypersensitivity to albuterol and any other PROAIR HFA Inhalation Aerosol Components. ( 4) WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue PROAIR HFA immediately and treat wi Přečtěte si celý dokument