POLYMYXIN B FOR INJECTION USP POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

POLYMYXIN B (POLYMYXIN B SULFATE)

Disponible depuis:

STERIMAX INC

Code ATC:

J01XB02

DCI (Dénomination commune internationale):

POLYMYXIN B

Dosage:

50MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

POLYMYXIN B (POLYMYXIN B SULFATE) 50MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

SINGLE VIAL

Type d'ordonnance:

Prescription

Domaine thérapeutique:

POLYMYXINS

Descriptif du produit:

Active ingredient group (AIG) number: 0153043001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-11-16

Résumé des caractéristiques du produit

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_Polymyxin B for Injection USP _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
POLYMYXIN B FOR INJECTION USP
Powder for Solution
Polymyxin B, 50 mg/vial (500,000 units)
(as polymyxin B sulphate)
Antibiotic
SteriMax Inc.
1-2735 Matheson Blvd. East
Mississauga ON
L4W 4M8
Date of Preparation:
November 9, 2011
Submission Control No: 143565
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_Polymyxin B for Injection _
_Page 2 of 26_
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
..................................................................................................10
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL
INFORMATION..........................................................................18
CLINICAL
TRIALS..........................................................................................................19
DETAIL