MORPHINE SULFATE INJECTION, USP SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MORPHINE SULFATE

Saatavilla:

FRESENIUS KABI CANADA LTD

ATC-koodi:

N02AA01

INN (Kansainvälinen yleisnimi):

MORPHINE

Annos:

10MG

Lääkemuoto:

SOLUTION

Koostumus:

MORPHINE SULFATE 10MG

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

100

Prescription tyyppi:

Narcotic (CDSA I)

Terapeuttinen alue:

OPIATE AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0104545001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-05-15

Valmisteyhteenveto

Morphine Sulfate Injection, USP 2 mg/mL, 4 mg/mL and 10 mg/mL_ _
Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MORPHINE SULFATE INJECTION, USP
Sterile Solution for Injection: 2 mg / mL, 4 mg / mL and 10 mg / mL
in Simplist
TM
prefilled single use syringes
Intravenous, Intramuscular, and Subcutaneous
Narcotic Analgesic
Fresenius Kabi Canada Inc.
Date of Preparation: May 15, 2019
165 Galaxy Blvd., Suite 100
Toronto, ON
M9W 0C8
Submission Control Number: 215897
Morphine Sulfate Injection, USP 2 mg/mL, 4 mg/mL and 10 mg/mL_ _
Page 2 of 37
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
.............................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
22
STORAGE AND STABILITY
......................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.....................................................................