INTAL INHALER METERED-DOSE AEROSOL

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CROMOLYN SODIUM

Tilgængelig fra:

SANOFI-AVENTIS CANADA INC

ATC-kode:

R03BC01

INN (International Name):

CROMOGLICIC ACID

Dosering:

1MG

Lægemiddelform:

METERED-DOSE AEROSOL

Sammensætning:

CROMOLYN SODIUM 1MG

Indgivelsesvej:

INHALATION

Enheder i pakken:

200 DOSES

Recept type:

Prescription

Terapeutisk område:

MAST-CELL STABILIZERS

Produkt oversigt:

Active ingredient group (AIG) number: 0108810005; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2007-02-28

Produktets egenskaber

PRODUCT
MONOGRAPH
INTAL
®
INHALER
(Sodium Cromoglycate Inhalation Aerosol)
1 mg/metered dose
Prophylaxis of Symptoms of Bronchial Asthma
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
April 26, 2006
Laval, Quebec H7L 4A8
Submission Control No. 105389
s-a Version 1.0 dated
2
PRODUCT MONOGRAPH
INTAL® Inhaler
(Sodium Cromoglycate Inhalation Aerosol)
1mg/metered dose
THERAPEUTIC CLASSIFICATION
Prophylaxis of Symptoms of Bronchial Asthma
ACTION AND CLINICAL PHARMACOLOGY
In vitro and in vivo animal studies have shown that sodium
cromoglycate inhibits sensitized mast
cell degranulation which occurs after exposure to specific antigens.
Sodium cromoglycate acts by
inhibiting the release of mediators from mast cells. Studies show that
sodium cromoglycate
indirectly blocks calcium ions from entering the mast cell, thereby
preventing mediator release.
Sodium cromoglycate inhibits both the immediate and non-immediate
bronchoconstrictive reactions
to inhaled allergens. Sodium cromoglycate also attenuates bronchospasm
caused by exercise, toluene
diisocyanate, aspirin, cold air, sulfur dioxide and environmental
pollutants in some patients.
Sodium cromoglycate has no intrinsic bronchodilator antihistaminic or
anti-inflammatory activity.
INDICATIONS AND CLINICAL USE
INTAL (sodium cromoglycate), a prophylactic agent, is indicated as an
adjunct in the management
of intrinsic and extrinsic asthma. It is used on a continuous basis to
prevent the symptoms associated
with asthma.
INTAL is also indicated for use in the prevention of bronchospasm
induced by known precipitating
factors such as exercise, cold air, allergens, and environmental
pollutants.
CONTRAINDICATIONS
Hypersensitivity to components of INTAL.
3
WARNING
INTAL Inhaler has no role in the treatment of an acute attack of
asthma, especially status
asthmaticus.
Severe
anaphylactic
reactions
can
occur
after
sodium
cromoglycate
administration.
The
recommended dosage should be decreased in patients with decreased
renal or hepatic function.
INTAL Inhal