Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MORPHINE SULFATE
ICU MEDICAL CANADA INC
N02AA01
MORPHINE
5MG
SOLUTION
MORPHINE SULFATE 5MG
INTRAVENOUS
30ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545003; AHFS:
CANCELLED POST MARKET
2019-10-14
_ _ _N_ _MORPHINE SULFATE INJECTION USP _ _Page 1 of 32 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N MORPHINE SULFATE INJECTION USP Sterile Solution 1 mg/mL, 5 mg/mL Narcotic Analgesic ICU Medical Canada Inc. 2600, Alfred-Nobel boul., suite 100 Saint-Laurent, QC H4S 0A9 Date of Revision: April 4, 2018 Submission Control No: 211418 _ _ _N_ _MORPHINE SULFATE INJECTION USP _ _Page 2 of 32 _ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ............................................................20 STORAGE AND STABILITY ..........................................................................................22 SPECIAL HANDLING INSTRUCTIONS .......................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23 PART II: SCIENTIFIC INFORMATION ................................................................................24 PHARMACEUTICAL INFORMATION .................................................................. Perskaitykite visą dokumentą