PHL-SALBUTAMOL ORAL LIQUID SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SALBUTAMOL (SALBUTAMOL SULFATE)

Verfügbar ab:

PHARMEL INC

ATC-Code:

R03CC02

INN (Internationale Bezeichnung):

SALBUTAMOL

Dosierung:

0.4MG

Darreichungsform:

SOLUTION

Zusammensetzung:

SALBUTAMOL (SALBUTAMOL SULFATE) 0.4MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

250ML

Verschreibungstyp:

Prescription

Therapiebereich:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108887004; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2016-10-25

Fachinformation

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