Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MORPHINE SULFATE
SANDOZ CANADA INCORPORATED
N02AA01
MORPHINE
25MG
SOLUTION
MORPHINE SULFATE 25MG
INTRAMUSCULAR
1/4ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545005; AHFS:
CANCELLED POST MARKET
2023-07-28
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MORPHINE HP 25 Morphine sulfate injection USP 25 mg/mL MORPHINE HP 50 Morphine sulfate injection USP 50 mg/mL Narcotic Analgesic Sandoz Canada Inc. 110 rue de Lauzon Date of Revision: May 17, 2019 Boucherville, QC, Canada J4B 1E6 Submission Control No: 221205 _Morphine HP 25 / Morphine HP 50_ _Page 2 of 31 _ 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 ......................................................................................... 21 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 21 PART II: SCIENTIFIC INFORMATION ............................................................................... 23 REFERENCES ................................................................................................................. 23 PART Perskaitykite visą dokumentą