M-EDIAT CAPSULE (IMMEDIATE RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MORPHINE SULFATE

Commercializzato da:

ETHYPHARM INC

Codice ATC:

N02AA01

INN (Nome Internazionale):

MORPHINE

Dosaggio:

5MG

Forma farmaceutica:

CAPSULE (IMMEDIATE RELEASE)

Composizione:

MORPHINE SULFATE 5MG

Via di somministrazione:

ORAL

Confezione:

20/50

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0104545003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2008-12-05

Scheda tecnica

_ _
_M-Ediat_
_®_
_ (morphine sulfate immediate release capsules) _
_Page 1 of 36_
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
M-EDIAT
®
Morphine Sulfate Immediate Release Capsules
5 mg, 10 mg, 20 mg and 30 mg
Opioid Analgesic
NOT A PRODUCT MONOGRAPH
Ethypharm Inc.
1000 de la Gauchetière Ouest, Suite 2400
Montréal, Québec
H3B 4W5
Date of Revision:
August 15, 2018
Control No.: 217210
_ _
_M-Ediat_
_®_
_ (morphine sulfate immediate release capsules) _
_Page 2 of 36 _
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
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHA