SALBUTAMOL HFA METERED-DOSE AEROSOL

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

SALBUTAMOL (SALBUTAMOL SULFATE)

Saadav alates:

SANIS HEALTH INC

ATC kood:

R03AC02

INN (Rahvusvaheline Nimetus):

SALBUTAMOL

Annus:

100MCG

Ravimvorm:

METERED-DOSE AEROSOL

Koostis:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Manustamisviis:

INHALATION

Ühikuid pakis:

200 DOSES

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2014-02-10

Toote omadused

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_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
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_Page 2 of 24_
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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
...................................