MYLAN-SALBUTAMOL RESPIRATOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

R03AC02

INN (Mezinárodní Name):

SALBUTAMOL

Dávkování:

5MG

Léková forma:

SOLUTION

Složení:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Podání:

INHALATION

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0108887006; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2012-10-19

Charakteristika produktu

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