RATIO-IPRA SAL UDV SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IPRATROPIUM BROMIDE; SALBUTAMOL (SALBUTAMOL SULFATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

R03AL02

INN (nume internaţional):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dozare:

0.5MG; 2.5MG

Forma farmaceutică:

SOLUTION

Compoziție:

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

Calea de administrare:

INHALATION

Unități în pachet:

2.5 ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2019-11-28

Caracteristicilor produsului

PRODUCT MONOGRAPH
Pr
ratio-IPRA SAL UDV
(Ipratropium Bromide Monohydrate and Salbutamol Sulfate)
INHALATION 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
BRONCHODILATOR
Teva Canada Limited.
Date of Preparation:
30 Novopharm Court July 24, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166253
ratio-IPRA SAL UDV Product Monograph
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
...............................................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................................
3
ADVERSE REACTIONS
................................................................................................................
6
DRUG INTERACTIONS
..............................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 12
STORAGE AND STABILITY
.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.................