APO-SALBUTAMOL HFA METERED-DOSE AEROSOL

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

SALBUTAMOL (SALBUTAMOL SULFATE)

Saadav alates:

APOTEX INC

ATC kood:

R03AC02

INN (Rahvusvaheline Nimetus):

SALBUTAMOL

Annus:

100MCG

Ravimvorm:

METERED-DOSE AEROSOL

Koostis:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Manustamisviis:

INHALATION

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2019-08-09

Toote omadused

_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_
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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
...................................................................................................
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
..........