KADIAN CAPSULE (SUSTAINED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MORPHINE SULFATE

Dostępny od:

BGP PHARMA ULC

Kod ATC:

N02AA01

INN (International Nazwa):

MORPHINE

Dawkowanie:

50MG

Forma farmaceutyczna:

CAPSULE (SUSTAINED-RELEASE)

Skład:

MORPHINE SULFATE 50MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Narcotic (CDSA I)

Dziedzina terapeutyczna:

OPIATE AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0104545006; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2003-07-02

Charakterystyka produktu

_ _
_Product Monograph KADIAN_
_®_
_ _
_Date of Revision: March 8, 2018 _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
KADIAN
®
morphine sulphate pentahydrate
Morphine Sulphate Sustained Release Capsules
10 mg, 20 mg, 50 mg and 100 mg
Oral
Manufacturer’s Standard
Opioid Analgesic
BGP Pharma.ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Approval:
August 11, 2015
Date of Revision:
March 8, 2018
®
Registered trademark of BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6.
Submission Control No: 209592
_ _
_Product Monograph KADIAN_
_®_
_ _
_Date of Revision: March 8, 2018 _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
Serious Warnings and Precautions (3); DOSAGE AND ADMINISTRATION (4);
WARNINGS
AND PRECAUTIONS (7), Endocrine and Metabolism; Neurologic; Sexual
Health. ADVERSE
REACTIONS (8), Post-Market Adverse Reactions (8.2). DRUG INTERACTIONS
(9), Drug-Drug
Interactions (9.1). PATIENT MEDICATION INFORMATION. FEB 2018
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ......................................................................................2
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
....................................................................................................................4
1.1
Pediatrics
....................................................................................................................4
1.2
Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................5
4
DOSAGE AND ADMINISTRATION .........................................................................