APO-SALBUTAMOL HFA METERED-DOSE AEROSOL

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostępny od:

APOTEX INC

Kod ATC:

R03AC02

INN (International Nazwa):

SALBUTAMOL

Dawkowanie:

100MCG

Forma farmaceutyczna:

METERED-DOSE AEROSOL

Skład:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Droga podania:

INHALATION

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-08-09

Charakterystyka produktu

_Page 1 of 25_
PRODUCT MONOGRAPH
PR
APO-SALBUTAMOL HFA
salbutamol pressurised inhalation, suspension
Mfr. Std.
100 mcg salbutamol (as salbutamol sulfate) / metered dose
Bronchodilator
(beta
2
-adrenergic agonist)
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Revision:
June 25, 2021
Submission Control No.: 252563
_ _
_Page 2 of 25_
_ _
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
...................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND
STABILITY..........................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
................................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
..........