RATIO-IPRA SAL UDV SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

इसे खरीदें

सक्रिय संघटक:

IPRATROPIUM BROMIDE; SALBUTAMOL (SALBUTAMOL SULFATE)

थमां उपलब्ध:

TEVA CANADA LIMITED

ए.टी.सी कोड:

R03AL02

INN (इंटरनेशनल नाम):

SALBUTAMOL AND IPRATROPIUM BROMIDE

डोज़:

0.5MG; 2.5MG

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

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

प्रशासन का मार्ग:

INHALATION

पैकेज में यूनिट:

2.5 ML

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

ANTIMUSCARINICS ANTISPASMODICS

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2019-11-28

उत्पाद विशेषताएं

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