Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
MYLAN PHARMACEUTICALS ULC
R03AC02
SALBUTAMOL
5MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 5MG
INHALATION
10ML
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887006; AHFS:
CANCELLED POST MARKET
2012-10-19
PRODUCT MONOGRAPH MYLAN-SALBUTAMOL RESPIRATOR SOLUTION _(Salbutamol Sulphate Inhalation Solution)_ 5 mg/mL Bronchodilator Mylan Pharmaceuticals ULC Date of Preparation: 85 Advance Road June 9, 2009 Etobicoke, Ontario M8Z 2S6 Control#: 130472 2 NAME OF DRUG MYLAN-SALBUTAMOL RESPIRATOR SOLUTION (Salbutamol Sulphate Inhalation Solution) 5 mg/mL THERAPEUTIC CLASSIFICATION Bronchodilator, beta 2 -adrenergic stimulant CLINICAL PHARMACOLOGY Salbutamol produces bronchodilation through stimulation of beta 2 -adrenergic receptors in bronchial smooth muscle, thereby causing relaxation of muscle fibers. This action is manifested by an increase in pulmonary function as demonstrated by spirometric measurements. A measurable decrease in airway resistance is typically observed 5 to 15 minutes after inhalation of salbutamol. The onset of maximum improvement in pulmonary function usually occurs after 60 to 90 minutes, and significant bronchodilator activity has been maintained from 3 to 6 hours. INDICATIONS AND CLINICAL USE Treatment of severe bronchospasm associated with exacerbations of chronic bronchitis and bronchial asthma. It can be used by "wet" nebulization. When administered through a nebulizer, it should be used with compressed air or oxygen. CONTRAINDICATIONS Hypersensitivity to any of the ingredients and in patients with cardiac tachyarrhythmias. Respirator solution use in children under 5 has not been established. WARNINGS In accordance with the present practice for asthma treatment, concomitant anti-inflammatory therapy should be part of the regimen if salbutamol respirator solution needs to be used on a regular daily basis (see DOSAGE AND ADMINISTRATION). Pregnancy and Lactation: The safety of salbutamol in pregnancy and in lactation has not been established. 3 In common with other β-adrenergic agents, salbutamol can induce reversible metabolic changes. These are most pronounced during infusions of the drug and include hyperglycemia and hypokalemia. Potentially serious hypokalemia may result from β 2 -agonist ther Perskaitykite visą dokumentą