MORPHINE HP 25 - 25MG/ML SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MORPHINE SULFATE

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

N02AA01

INN (International Nazwa):

MORPHINE

Dawkowanie:

25MG

Forma farmaceutyczna:

SOLUTION

Skład:

MORPHINE SULFATE 25MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

1/4ML

Typ recepty:

Narcotic (CDSA I)

Dziedzina terapeutyczna:

OPIATE AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0104545005; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2023-07-28

Charakterystyka produktu

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