País: Canadá
Língua: inglês
Origem: Health Canada
POLYMYXIN B (POLYMYXIN B SULFATE)
STERIMAX INC
J01XB02
POLYMYXIN B
50MG
POWDER FOR SOLUTION
POLYMYXIN B (POLYMYXIN B SULFATE) 50MG
INTRAMUSCULAR
SINGLE VIAL
Prescription
POLYMYXINS
Active ingredient group (AIG) number: 0153043001; AHFS:
APPROVED
2011-11-16
_ _ _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 Leia o documento completo