Kraj: Kanada
Język: angielski
Źródło: Health Canada
MORPHINE SULFATE
BGP PHARMA ULC
N02AA01
MORPHINE
100MG
CAPSULE (SUSTAINED-RELEASE)
MORPHINE SULFATE 100MG
ORAL
50
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545012; AHFS:
APPROVED
2003-07-02
_ _ _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 ......................................................................... Przeczytaj cały dokument