Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
IVAX PHARMACEUTICALS INCORPORATED
R03AC02
SALBUTAMOL
1MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 1MG
INHALATION
100
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887007; AHFS:
CANCELLED PRE MARKET
2018-07-24
PRODUCT MONOGRAPH SALBUTAMOL INHALATION SOLUTION (salbutamol sulphate respirator solution) 1 mg salbutamol/mL (2.5 mg/2.5 mL) in unit dose nebules 2 mg salbutamol/mL (5 mg/2.5 mL) in unit dose nebules BRONCHODILATOR (beta 2 -adrenergic stimulant) MANUFACTURER: IVAX PHARMACEUTICALS INC DATE OF PREPARATION: 05 JUNE, 2001 4400 BISCAYNE BLVD., MIAMI, FLORIDA, USA DATE OF REVISION: 26 FEBRUARY, 2004 33137 CONTROL # 089878 DISTRIBUTED BY: IVAX PHARMACEUTICALS CANADA INC. 1 PLACE VILLE-MARIE, SUITE 3900 MONTREAL, QUEBEC, CANADA H3B 4M7 2 PRODUCT MONOGRAPH SALBUTAMOL INHALATION SOLUTION (salbutamol sulphate respirator solution) 1 mg salbutamol/mL (2.5 mg/2.5 mL) in unit dose nebules 2 mg salbutamol/mL (5 mg/2.5 mL) in unit dose nebules 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 bronchial muscle fibres. This action is manifested by an improvement 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 maximum improvement in pulmonary function usually occurs 60 to 90 minutes after salbutamol treatment, and significant bronchodilator activity has been observed to persist for 3 to 6 hours. INDICATIONS AND CLINICAL USE SALBUTAMOL INHALATION SOLUTION (salbutamol sulphate respirator solution) is indicated for the treatment of severe bronchospasm associated with exacerbations of chronic bronchitis and bronchial asthma. They can be used by "wet" nebulization. When administered through a nebulizer, salbutamol respirator solutions should be used with compressed air or oxygen. 3 CONTRAINDICATIONS Salbutamol is contraindicated in patients with a hypersensitivity to any of the ingredients and in patients with tachyarrythmias. WARNINGS USE OF ANTI-INFLAMMATORY AGENTS: In accordance with the present practice for asthma treatment, concomitant a Aqra d-dokument sħiħ