APO-SALVENT-IPRAVENT STERULES SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

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

Tilgængelig fra:

APOTEX INC

ATC-kode:

R03AL02

INN (International Name):

SALBUTAMOL AND IPRATROPIUM BROMIDE

Dosering:

0.5MG; 2.5MG

Lægemiddelform:

SOLUTION

Sammensætning:

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

Indgivelsesvej:

INHALATION

Enheder i pakken:

20X2.5ML

Recept type:

Prescription

Terapeutisk område:

ANTIMUSCARINICS ANTISPASMODICS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2005-03-31

Produktets egenskaber

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PRODUCT MONOGRAPH
PR
APO-SALVENT IPRAVENT STERULES
Salbutamol Sulfate and Ipratropium Bromide Inhalation Solution
Each sterule contains 3 mg salbutamol sulfate [2.5 mg salbutamol base]
and 0.5 mg of
ipratropium bromide anhydrous [as monohydrate] in 2.5 mL of saline
BRONCHODILATOR
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
June 22, 2018
Toronto, Ontario M9L 1T9
Control No. 215519
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION ...............................................................................
3
INDICATIONS AND CLINICAL USE .....................................................................................
3
CONTRAINDICATIONS ..........................................................................................................
3
WARNINGS AND PRECAUTIONS .........................................................................................
4
ADVERSE REACTIONS ...........................................................................................................
8
DRUG INTERACTIONS .........................................................................................................
13
DOSAGE AND ADMINISTRATION .....................................................................................
14
OVERDOSAGE .......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY ...................................................................
16
STORAGE AND STABILITY .................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 22
PART II: SCIENTIFIC INFORMATION
...........................................................................
23
PHARMACEUTICAL INFORMATION .................................................................................
23
C