TEVA-COMBO STERINEBS SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

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

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

R03AL02

INN (Medzinárodný Name):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dávkovanie:

2.5MG; 0.5MG

Forma lieku:

SOLUTION

Zloženie:

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

Spôsob podávania:

INHALATION

Počet v balení:

2.5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTIMUSCARINICS ANTISPASMODICS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2009-09-03

Súhrn charakteristických

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