POLYMYXIN B FOR INJECTION USP POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

POLYMYXIN B (POLYMYXIN B SULFATE)

Διαθέσιμο από:

STERIMAX INC

Φαρμακολογική κατηγορία (ATC):

J01XB02

INN (Διεθνής Όνομα):

POLYMYXIN B

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

POLYMYXIN B (POLYMYXIN B SULFATE) 50MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

SINGLE VIAL

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

POLYMYXINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2011-11-16

Αρχείο Π.Χ.Π.

_ _
_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
_ _
_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