TEVA-SALBUTAMOL HFA METERED-DOSE AEROSOL

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

R03AC02

INN (Medzinárodný Name):

SALBUTAMOL

Dávkovanie:

100MCG

Forma lieku:

METERED-DOSE AEROSOL

Zloženie:

SALBUTAMOL (SALBUTAMOL SULFATE) 100MCG

Spôsob podávania:

INHALATION

Počet v balení:

200 DOSES

Typ predpisu:

Prescription

Terapeutické oblasti:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0108887013; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2009-12-07

Súhrn charakteristických

_Page 1_
PRODUCT MONOGRAPH
Pr
TEVA-SALBUTAMOL HFA
salbutamol (as salbutamol sulfate)
Inhalation Aerosol
100 mcg salbutamol per actuation
Bronchodilator
(beta
2
-adrenergic agonist)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 213098
Date of Revision:
March 20, 2018
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
10
DOSAGE AND ADMINISTRATION
..............................................................................
11
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
..........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
..........................................................................
16
CLINICAL TRIALS
..........................