SALBUTAMOL HFA METERED-DOSE AEROSOL

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

SALBUTAMOL (SALBUTAMOL SULFATE)

Prieinama:

SANIS HEALTH INC

ATC kodas:

R03AC02

INN (Tarptautinis Pavadinimas):

SALBUTAMOL

Dozė:

100MCG

Vaisto forma:

METERED-DOSE AEROSOL

Sudėtis:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Vartojimo būdas:

INHALATION

Vienetai pakuotėje:

200 DOSES

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0108887003; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2014-02-10

Prekės savybės

_ _
_ _
_ _
_Page 1 of 24_
PRODUCT MONOGRAPH
PR
SALBUTAMOL HFA
salbutamol sulfate inhalation aerosol
(100 mcg salbutamol/metered dose)
Bronchodilator
(beta
2
-adrenergic agonist)
SANIS HEALTH INC.
1 Presidents Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
July 3, 2018
Submission Control No.: 216774
_ _
_ _
_ _
_ _
_Page 2 of 24_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
...................................