TEVA-COMBO STERINEBS SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

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

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

R03AL02

INN (Kansainvälinen yleisnimi):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Annos:

2.5MG; 0.5MG

Lääkemuoto:

SOLUTION

Koostumus:

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

Antoreitti:

INHALATION

Kpl paketissa:

2.5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTIMUSCARINICS ANTISPASMODICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2009-09-03

Valmisteyhteenveto

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
..................................................................................