RATIO-IPRA SAL UDV SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IPRATROPIUM BROMIDE; SALBUTAMOL (SALBUTAMOL SULFATE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

R03AL02

INN (Kansainvälinen yleisnimi):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Annos:

0.5MG; 2.5MG

Lääkemuoto:

SOLUTION

Koostumus:

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

Antoreitti:

INHALATION

Kpl paketissa:

2.5 ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTIMUSCARINICS ANTISPASMODICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2019-11-28

Valmisteyhteenveto

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