TEVA-COMBO STERINEBS SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

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

Доступна з:

TEVA CANADA LIMITED

Код атс:

R03AL02

ІПН (Міжнародна Ім'я):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Дозування:

2.5MG; 0.5MG

Фармацевтична форма:

SOLUTION

Склад:

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

Адміністрація маршрут:

INHALATION

Одиниць в упаковці:

2.5ML

Тип рецепту:

Prescription

Терапевтична области:

ANTIMUSCARINICS ANTISPASMODICS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2009-09-03

Характеристики продукта

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