TEVA-COMBO STERINEBS SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SALBUTAMOL (SALBUTAMOL SULFATE); IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE)

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

R03AL02

INN (Internationale Bezeichnung):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dosierung:

2.5MG; 0.5MG

Darreichungsform:

SOLUTION

Zusammensetzung:

SALBUTAMOL (SALBUTAMOL SULFATE) 2.5MG; IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 0.5MG

Verabreichungsweg:

INHALATION

Einheiten im Paket:

2.5ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTIMUSCARINICS ANTISPASMODICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0232902001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-09-03

Fachinformation

PAGE 1 OF 48
PRODUCT MONOGRAPH
Pr
TEVA-COMBO STERINEBS
®
(salbutamol sulphate and ipratropium bromide Nebulizer Solution)
Each Unit Dose Vial (UDV) contains 0.50 mg of ipratropium bromide (as
ipratropium bromide monohydrate) and 2.5 mg salbutamol (as salbutamol
sulphate)
in 2.5 mL of saline
BRONCHODILATOR
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No:
191820
Date of Revision:
March 1, 2016
PAGE 2 OF 48
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY
PRODUCT
INFORMATION
.....................................................................................
3
INDICATIONS
AND
CLINICAL
USE
...........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
4
WARNINGS
AND
PRECAUTIONS
...............................................................................................
4
ADVERSE
REACTIONS
................................................................................................................
9
DRUG
INTERACTIONS
...............................................................................................................
15
DOSAGE
AND
ADMINISTRATION
...........................................................................................
16
OVERDOSAGE
.............................................................................................................................
18
ACTION
AND
CLINICAL
PHARMACOLOGY
..........................................................................
18
STORAGE
AND
STABILITY
.......................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...........................................................
26
PART II: SCIENTIFIC INFORMATION
..................................................................................