Ország: Kanada
Nyelv: angol
Forrás: Health Canada
MORPHINE SULFATE
PFIZER CANADA ULC
N02AA01
MORPHINE
2MG
SOLUTION
MORPHINE SULFATE 2MG
INTRAMUSCULAR
10X1 ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545008; AHFS:
CANCELLED PRE MARKET
2019-03-04
_ _ _Product Monograph - _ _N_ _MORPHINE SULFATE INJECTION USP _ _Page 1 of 33 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N MORPHINE SULFATE INJECTION USP Sterile Solution 2 mg/mL, 10 mg/mL and 15 mg/mL Narcotic Analgesic Pfizer Canada Inc 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: October 3, 2018 Submission Control No: 219782 _ _ _Product Monograph - _ _N_ _MORPHINE SULFATE INJECTION USP _ _Page 2 of 33 _ 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 ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................22 SPECIAL HANDLING INSTRUCTIONS .......................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ................................................................................24 PHARMACEUTICAL INFORMATION ................... Olvassa el a teljes dokumentumot