Kraj: Kanada
Język: angielski
Źródło: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
PHARMEL INC
R03CC02
SALBUTAMOL
0.4MG
SOLUTION
SALBUTAMOL (SALBUTAMOL SULFATE) 0.4MG
ORAL
250ML
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887004; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PHL-SALBUTAMOL ORAL LIQUID _(Salbutamol Sulphate Solution)_ Oral Liquid, 0.4 mg/mL Bronchodilator (beta 2 -adrenergic stimulant) P HARMEL I NC . Date of Preparation: 8699, 8e Avenue November 19, 2004 Montreal, Quebec H1Z 2X4 CONTROL NO. 095317 2 PRODUCT MONOGRAPH NAME OF DRUG phl-SALBUTAMOL ORAL LIQUID (Salbutamol Sulphate Solution) 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 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 30 minutes after an oral dose of salbutamol sulphate. The maximum improvement in pulmonary function usually occurs after 2 to 3 hours, and significant bronchodilator activity has been observed to persist for 6 hours or longer. INDICATIONS AND CLINICAL USE Prevention or relief of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor. CONTRAINDICATIONS Hypersensitivity to any of the ingredients and in patients with tachyarrhythmias. Salbutamol Sulphate Oral Liquid is not recommended in children under two years of age, until the dosage regimen and evidence concerning its safety have been established. 3 WARNINGS USE OF ANTI-INFLAMMATORY AGENTS: In accordance with the present practice for asthma treatment, concomitant anti-inflammatory therapy should be part of the regimen if salbutamol needs to be used on a regular daily basis (see DOSAGE AND ADMINISTRATION). It is essential that the physician instruct the patient in the need for further evaluation if the patient’s asthma becomes worse. DETERIORATION OF ASTHMA: The management of asthma should normally follow a stepwise program and patient response should be monitored clinically and by lung fun Przeczytaj cały dokument